Single use bioprocess bags have recently found application in the biopharmaceutical industry as they do not require use of extensive cleaning and sterilization procedures, and are easier to use during initial and pilot-scale process development compared to traditional glass and steel equipment. The manufacturing processes for these bags often require use of additives that may leach out into the media and adversely affect the growth of cells in these plastic bags. The toxicities of bis(2,4-di-tert-butylphenyl)phosphate (bDtBPP), a degradant of an antioxidant stabilizer, and a plasticizer additive trihexyl O-acetylcitrate (tHAC), were tested on adherent and suspended CHO-K1 cell culture in serum-containing media, as well as chemically defined serum-free media. The low EC50 values for these compounds suggested that both bDtBPP and tHAC were toxic to CHO-K1 cells. The effect of mixing, culture volume, and exposure duration on toxicity of leachates was assessed by determining the EC50 values of bDtBPP on CHO-K1 cells. After gauging the toxicity of bDtBPP under these conditions, extracts leached from three lots of multi-layered plastic bags into water were tested on CHO-K1 cells to validate their use as disposable cell culture bags.

Evaluating the cytotoxicity of antioxidant and plasticizer additives used in single use cell culture bags

251st National Meeting (2016)

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